Cleared Traditional

K143664 - HeartSee

K143664 is an FDA 510(k) clearance for HeartSee, manufactured by University of Texas Medical School AT Houston. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K143664 · University of Texas Medical School AT Houston · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
112d
Days
Class 2
Risk

K143664 is an FDA 510(k) clearance for the HeartSee. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by University of Texas Medical School AT Houston (Houston, US). The FDA issued a Cleared decision on April 14, 2015 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K143664

510(k) Number K143664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2014
Decision Date April 14, 2015
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 107d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 465
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K143664.
Biograph Horizon PET/CT
K152880 · Siemens Medical Solutions USA, Inc. · Jan 2016
Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System
K151403 · Neusoft Medical Systems Co., Ltd. · Nov 2015
Biograph mCT and mCT Flow PET/CT Scanners
K151486 · Siemens Medical Solutions USA, Inc. · Jul 2015
Hermes Medical Imaging Suite v5.5
K142631 · Hermes Medical Solutions AB · Dec 2014
CORTEX ID SUITE
K141074 · Ge Medical Systems, LLC · Sep 2014
DISCOVERY IQ
K141477 · Ge Medical Systems, LLC · Sep 2014
K143664 · HeartSee
Download PDF FDA Summary University of Texas M…